An IND is a pre-market mechanism, not a marketing authorization. It lets a sponsor study an investigational product in humans under an FDA-reviewed protocol and institutional review board oversight, generating the data a later BLA or new drug application would rely on.
This matters for perinatal biologics because any product regulated as a section 351 biologic, including exosome preparations, would need an IND to be studied clinically before approval exists. FDA states that there are no FDA-approved exosome products; such products are generally regulated as biologic drugs under section 351, and purchase and clinical-use decisions belong to the physician, working with the physician's own regulatory counsel. FDA also reads a company's website, affiliate content, and social media as evidence of how a product is actually being used, separate from whatever protocol language a vendor applies to it.
An IND number is not the same thing as approval. A product used clinically without either an IND-governed study or an approved BLA has no FDA marketing authorization behind it. Clinics should ask a vendor directly what regulatory pathway, if any, a given product is operating under, and treat that answer as a documentation question for counsel rather than a clinical one.
These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.
An IND explains why a product can appear in a clinical study without being approved for sale, a distinction that affects how a buyer should read vendor claims.